Devices for Cardiac Surgery and Methods Thereof

This application is a continuation of U.S. patent application Ser. No. 17/673,404, filed Feb. 16, 2022, which is a continuation of U.S. patent application Ser. No. 16/380,755, filed Apr. 10, 2019, which claims priority to U.S. Provisional Patent Application No. 62/655,650, filed Apr. 10, 2018, U.S. Provisional Patent Application No. 62/747,095, filed Oct. 17, 2018, and U.S. Provisional Patent Application No. 62/790,663, filed Jan. 10, 2019, each of which is hereby incorporated by reference in its entirety.

The claimed invention relates to surgical devices, and more specifically to devices for cardiac surgery and methods thereof.

Various types of surgery require a surgeon to place and temporarily secure a suture during a given surgical procedure. For example, prior to cannulation in cardiac surgery, surgeons often place one or more purse string sutures around a target tissue site before an incision will be made for a cannula to be inserted. Then, after the incision is made at the target site and the cannula has been inserted, the one or more purse string sutures are cinched to pull the tissue against the cannula to ensure there is a good seal around the cannula. Since the cannula will be removed before the end of the procedure, it is not efficient to tie a knot in the suture ends holding the tissue against the cannula, since they will soon need to be untied. Furthermore, during a minimally invasive surgical technique, the surgical team may not have direct access to the suture where it exits the tissue, so it can be difficult to maintain a cinched pressure around the cannula.

One solution employed by surgeons in this situation is the use of a simple tube. The suture ends to be temporarily cinched are passed through a thin tube which reaches from the surgical site to a convenient location away from the surgical site. A distal end of the tube is placed against tissue where the suture exits the tissue and, while holding a proximal end of the tube, the suture ends exiting the proximal end of the tube are pulled to create a desired tension of the suture on the tissue near the distal end of the tube. Then, the proximal end of the tube is clamped with a mosquito clamp to maintain tension on the suture until it is desired to release the tension.

To provide selective locking of suture ends when working with tubes as described above, separate clamps or forceps are used. Unfortunately, when such devices are used to clamp a tube, the clamping efficacy can vary depending on the type of clamp selected, the age of the clamp, and even what part of the clamp's jaw is used to secure the tube. Since such clamp and tube combinations for suture management are often used to secure cannulation devices for cardio-pulmonary bypass, as well as during other procedures, it would be desirable to have a more robust, reliable, and easy-to-use suture locking apparatus.

In other types of cardiac surgery, it is often desirable to access the aortic valve and/or left ventricle of the heart through a portion of the aorta. In order to create an aortotomy (incision through the aorta), it is first necessary to securely clamp and/or occlude the aorta away from the heart, place the patient on bypass perfusion, and temporarily stop the heart from beating, for example, with cardioplegia. The aortotomy depressurizes the aorta and can cause the walls of the aorta to flop down after an incision is made in the aorta, thereby having the potential to block the surgeon's view of the aortic valve through the incision. Furthermore, even when the flaps of the aorta around the incision are held out of the way, it can still be difficult to see the aortic root where the leaflets of the aortic valve are attached to the heart. Therefore, it would be helpful if there were a device for cardiac surgery which could help to increase a surgeon's visualization of the aortic root in a minimally invasive surgical procedure.

A device for cardiac surgery is disclosed. The device for cardiac surgery includes an aortic root retractor frame; an introducer; one or more suture locking apparatuses; and a frame deployment mechanism.

A suture locking apparatus is also disclosed. The suture locking apparatus includes an upper housing having a first gripping surface, a lower housing coupled to the upper housing and having a second gripping surface, and a latch.

A method of stabilizing cardiac tissue is also disclosed. The method of stabilizing cardiac tissue includes placing three commissural sutures in each of three commissures in an aortic annulus; loading each of the three commissural sutures into corresponding but separate suture locking apparatuses coupled to an aortic root retractor frame; delivering and positioning the aortic root retractor frame into an aortic root; tensioning and locking the commissural sutures into the corresponding suture locking apparatuses; and deploying the aortic root retractor frame using a deployment suture coupled to the aortic root retractor frame.

It will be appreciated that for purposes of clarity and where deemed appropriate, reference numerals have been repeated in the figures to indicate corresponding features, and that the various elements in the drawings have not necessarily been drawn to scale in order to better show the features.

1 FIG.A 10 10 12 14 10 12 14 16 12 20 14 14 20 12 12 14 10 10 10 10 14 12 is a distal-top-left perspective view of an embodiment of a suture locking apparatus. The suture locking apparatushas an upper housingcoupled to a lower housing. In this embodiment of the suture locking apparatus, the upper housingis pivotably coupled to the lower housingby resting a hingeof the upper housingwithin a cradledefined by the lower housing. In other embodiments, the lower housingmay have a hinge resting in a cradledefined by the upper housing. Depending on the embodiment, the upper housingand lower housingmay be pivotably coupled at a distal endD of the suture locking apparatus, a proximal endP of the suture locking apparatus, or any location in between. In other embodiments, the lower housingand the upper housingmay be coupled with a continuous living hinge.

24 66 14 12 24 50 1 FIG.A 1 FIG.A A distal apertureconfigured to receive a suture and a suture tube(not shown in), is defined by the lower housingand the upper housing. This distal aperturedirects a suture or a suture tube into an internal channelor suture channel (not shown inbut discussed later). For the purposes of this disclosure, a distal direction or location refers to an orientation away from the surgeon or operator of the instrument. A proximal direction or location refers to an orientation towards the surgeon or operator of the instrument. It should be understood that the term “suture”, as used herein, is intended to cover any thread, cable, wire, filament, strand, line, yarn, gut, or similar structure, whether natural and/or synthetic, in monofilament, composite filament, or multifilament form (whether braided, woven, twisted, or otherwise held together), as well as equivalents, substitutions, combinations, and pluralities thereof for such materials and structures.

1 FIG.A 1 FIG.A 3 FIG.A 10 28 10 14 30 46 12 70 30 10 12 14 46 10 30 28 10 10 Still on, this embodiment of a suture locking apparatushas a latchon the distal portion of the suture locking apparatus. The lower housinghas one or more latch elementsconfigured to apply a force against a latch tab, not shown in, but visible in. The upper housingdefines a latch openingconfigured to receive the latch elements. In another embodiment of the suture locking apparatus, it may be the upper housingthat comprises one or more latch elements, and the lower housingthat comprises a latch opening and a latch tab. Depending on the embodiment of the suture locking apparatus, one or more latch elementsmay be present and the location of the latchmay be located on a proximal endP of the suture locking apparatus.

12 38 14 40 14 12 14 38 10 12 14 10 42 14 42 1 FIG.B 1 FIG.A One or more features are included in this embodiment is configured to provide ergonomic comfort or leverage for the operator or user. For example, the upper housinghas several recessesand the lower housinghas an ergonomic gripfor one or more digits of the user to rest upon or use as leverage during operation. In alternate embodiments, more than one ergonomic grip may be present in the lower housing, the upper housingmay have one or more ergonomic grips, and the lower housingmay have one or more recesses. Depending on the embodiment of the suture locking apparatus, either the upper housingor the lower housingmay lack ergonomic features.is a proximal-top-right perspective view of the suture locking apparatusof. This figure displays a proximal aperturedefined by the lower housingand configured to allow a suture (not shown in this view) to pass freely therethrough when unlocked or be held securely in place when the locking mechanism is engaged. It should be noted that the proximal aperturemay be defined in a variety of alternate shapes or physical configurations.

2 2 2 2 2 2 FIGS.A,B,C,D,E, andF 1 FIG.A 2 2 2 2 2 2 FIGS.A,B,C,D,E, andF 2 2 FIGS.A andE 7 FIG.A 7 FIG.A 10 10 10 12 14 are front, left side, right side, rear, top, and bottom elevational views, respectively, of the suture locking apparatus ofin an unlocked position. The suture locking apparatus, its distal endD, proximal endP, upper housing, and lower housingare indicated inwhere possible. The section plane cross-section lines bisectingrefer to the cross-section illustrated inand will be further described in regard to.

3 FIG.A 1 FIG.A 7 7 FIGS.A andB 14 10 14 44 30 30 30 46 10 30 12 70 14 14 48 14 12 12 14 is a proximal-top-left perspective view of the lower housingof the suture locking apparatusof. The lower housingdefines a latch recessto hold at least a portion of the one or more latch elements. The latch recess is sized and configured to allow flexure or motion of the latch elementsas required to move between their locked and unlocked position. The latch elementsand the latch tabsare configured to hold the suture locking apparatusin either the locked or unlocked position, which will be described later in regard to. The latch elementsengage the top surface of the upper housingat the edge of the latch opening. Towards the distal endD of the lower housingthere are two distal support strutsconfigured to restrict the relative motion of the lower housingand the upper housingby limiting the angle the upper housingpivots relative to the lower housing.

3 FIG.B 3 FIG.A 14 50 10 14 56 60 58 62 64 66 24 50 10 66 50 56 56 66 50 66 60 50 64 14 60 14 58 66 66 10 64 62 54 42 14 14 10 60 14 60 24 42 50 64 14 50 30 24 50 64 42 is a proximal-top perspective view of the lower housingof. This view demonstrates further details of an internal suture channeland other features configured to direct a suture (not shown in this view) into and through the suture locking apparatus. The lower housingdefines several interference barbs, a suture tube stop, a tube stop recess, lower teetheach having a lower tooth recess. A suture tubecan be inserted into the distal apertureand in connection with the channelas a guide to entrain a suture within the suture locking apparatus. The suture tubemay be further directed through or constrained in the channelby features such as the interference barbs. These interference barbsor bumps are configured to provide additional holding force to prevent the unintentional removal of a suture tubefrom the suture locking device. A sharper profile provides a one-way insertion path with additional resistance to removal through the channel. These interference barbs may have different shapes in alternate embodiments, such as rounded edges or sharper edges having different orientations. A suture tubemay be terminated with a metal flange, flared end or other fastener constructed to hold the suture in place within a tube stopwhich delineates the channelfrom the lower tooth recessesin the lower housingof the suture locking device. The tube stopis defined by the lower housing, which also defines a tube stop recesson either side for capturing a flange or flare on the end of a suture tube. One or more suture ends can be inserted or snared through the suture tube. The suture ends can then exit the suture locking apparatusvia the lower tooth recessesdefined by the lower teethand located in between two proximal support struts, and the proximal aperturedefined by the lower housingat its proximal endP. While the present embodiment of a suture locking apparatusshows a tube stopat the approximate midpoint along the length of the lower housing, the tube stopmay be located in any place along the length of the suture path between the distal apertureand the proximal aperture, and therefore the respective lengths and dimensions of the channel, lower tooth recesses, and other elements defined by the lower housingmay vary accordingly. In this embodiment, this channelpasses between the one or more latch elements, and the path the suture follows begins with the distal apertureand sequentially follows through the channel, the lower tooth recessesand exits at the proximal aperture.

62 64 14 14 62 62 62 62 60 14 10 12 14 54 10 10 10 10 10 10 44 66 68 60 58 14 60 58 66 60 58 3 FIG.C 3 3 FIGS.A-B The lower teethand the lower tooth recessesdefined by the lower housingin this embodiment form a lower gripping surface. The lower gripping surface as defined by the aforementioned features defined by the lower housingmay include one or more lower teeth. These one or more lower teethmay take a wide variety of shapes and forms. For instance, the one or more lower teethmay be formed of wedges, or of triangular saw teeth, but it will be apparent to those of ordinary skill in the art that these teeth may be formed of multiple shapes. The one or more lower teethmay further define lower recesses configured to receive a suture that has exited a tube which terminates at the tube stop. In alternative embodiments, the lower gripping surface may instead include a support pad or alternate method of providing a resilient grip. Still other alternative embodiments may provide other means of providing sufficient holding force or a torturous pathway useful in restraining the movement of a suture within a suture locking apparatus. Other embodiments may have one, or up to five or ten teeth or other elements in the lower housing. The number and shape of elements included in a gripping surface is limited only by the dimensions of the suture locking apparatusand the relative dimensions of the teeth or other elements defined by either the upper housingor the lower housing. In other embodiments, proximal support strutsmay extend from the proximal endP of the suture locking apparatusto the distal endD of the suture locking apparatus. In some embodiments, the support struts may extend from a proximal endP of the suture locking apparatusto the latch recess.is a top view of the lower housing ofwith a suture tube added to the lower housing. This view illustrates a suture tubehaving a flared endinserted into the suture locking device. The flared end is held within the tube stopand tube stop recessesdefined by the lower housing. While the end of the tube has been flared using heating to fit it within the tube stopand tube stop recesses, adhesive, heating, or both, as well as other means for fixing the suture tubewithin the tube stopand tube stop recessesmay be used for the assembly of this as well as similar assemblies as described herein.

4 FIG.A 1 FIG.A 3 FIG.A 12 10 12 70 16 76 74 78 78 80 82 80 12 12 16 72 52 14 52 72 12 14 76 24 66 80 82 12 12 80 80 80 80 60 12 10 12 14 80 62 76 50 60 64 42 74 80 62 is a proximal-bottom-left perspective view of upper housingof the suture locking apparatusof. The upper housingdefines the latch opening, two hinges, a distal upper housing notch, a proximal upper housing notch, and an inner surface. The inner surfacedefines two upper teethwhich each define an upper tooth recess. The upper teethare located towards the proximal endP of the upper housing. The hingesfurther comprise hinge protrusionsconfigured to mate with cradle apertureslocated in the lower housing, shown in. The cradle aperturesare comprised of an arc wider than that of the arcuate hinge protrusionsto allow pivoting of the upper housingrelative to the lower housing. The distal upper housing notchpartially defines the distal apertureand is configured to receive a suture tubeand a suture, not shown in this view. The upper teethand the upper tooth recessesdefined by the upper housingin this embodiment form an upper gripping surface. The upper gripping surface as defined by the aforementioned features defined by the upper housingmay include one or more upper teeth. These one or more upper teethmay take a wide variety of shapes and forms. For instance, the one or more upper teethmay be formed of wedges, or of triangular saw teeth, but it will be apparent to those of ordinary skill in the art that these teeth may be formed of multiple shapes. The one or more upper teethmay further define upper recesses configured to receive a suture that has exited a tube which terminates at the tube stop. In alternative embodiments, the upper gripping surface may instead include a support pad or alternate method of providing a resilient grip. Still other alternative embodiments may provide other means of providing sufficient holding force or a torturous pathway useful in restraining the movement of a suture within a suture locking apparatus. Other embodiments may have one, or up to five or ten teeth or other elements in the upper housing. The number and shape of elements included in a gripping surface is limited only by the dimensions of the suture locking apparatusand the relative dimensions of the teeth or other elements defined by either the upper housingor the lower housing. In a locked position, the upper teethinterlock with the lower teethin a staggered fashion, restricting the suture in a tortuous path, which fixes the suture ends in place without allowing the suture ends to move in either direction. This is advantageous in a surgical procedure, as it locks the suture at the required tension desired by the operator, with no slippage. In an unlocked position, the upper gripping surfaces and the lower gripping surfaces are configured to allow unrestricted movement of a suture along a pathway defined by the distal notch, the channel, past the tube stop, through the lower tooth recessesand finally via the proximal aperturedefined by the proximal upper housing notch. In this unlocked position, the upper teethand the lower teethare no longer interlocking, and allow the suture ends to move in either direction as desired by the operator.

4 FIG.B 1 FIG.A 12 10 34 70 12 34 34 is a proximal-bottom perspective view of the upper housingof the suture locking apparatusoffurther detailing a latch steplocated adjacent to the latch openingin the upper housing. This latch stepis configured to hold the latch elements in a locked or unlocked position, as selected by the operator. The latch tabs are biased against the latch stepto provide resistance to engagement and disengagement of the latch elements unless intentionally selected by the operator.

5 5 FIGS.A-B 5 FIG.A 5 FIG.B 5 FIG.B 5 5 FIGS.A andB 84 84 84 86 84 84 88 90 92 88 90 92 84 94 96 98 98 94 84 100 101 102 101 94 104 88 106 86 88 108 110 84 104 108 110 104 108 110 96 100 84 88 90 92 84 are unfolded proximal-top-right and folded distal-top-left perspective views, respectively, of an embodiment of an aortic root retractor frame.illustrates the ARR framein an unfolded orientation. The aortic root retractor frameis a continuous article of plastic defining several features configured to fulfill its purpose as a foldable or collapsible frame capable of deploying to an open position wherein the frame provides structure and visibility to an aorta during surgical procedures. The ARR framedefines two living hingeswhich are configured to reversibly fold the ARR framefrom the folded orientation to a deployed orientation, which will be illustrated in. The ARR framefurther defines a first paddle, a second paddle, and a third paddleconfigured to hold open and support the walls of an aorta during a surgical procedure. The three paddles,,are also known as U-paddles due to their shape in this embodiment, although alternate embodiments may have paddles having other shapes or physical arrangements. The ARR framealso defines a first geometric mating featureat one end having two suture guidesand an angled surface configured to mate with a second geometric mating featurethat also defines an angled surface. The second geometric mating feature, which overlaps and mates with the first geometric mating featurewhen the ARR frameis in a deployed or closed position, also defines two suture guides,surrounding either side of a deployment tube orifice. Suture guideis configured to receive a pin from an ARR frame delivery device or ARR frame introducer device, which will be described later. Adjacent to the first geometric mating featureis a tube orificeand the first paddle. Partially visible is a pin receiving orifice, adjacent to the living hingeadjacent to the first paddle. Two additional tube orifices,are spaced around the ARR frame. The tube orifices,,are configured to hold the suture tubes used for organizing and entraining sutures (not shown in this view) associated with an ARR frame delivery device which will be discussed later. The orientation of these tube orifices,,and suture guides,with respect to the identifying features of the aortic annulus or aortic root will be described later.illustrates the ARR framein a folded orientation. The position of the first paddle, second paddle, and the third paddle, as well as the other features of the ARR framein the folded orientation should be noted. While this embodiment shown inis made from a plastic material, other materials suitable for surgical procedures requiring such a frame, such as stainless steel, other metals, or other plastics, are known to those skilled in the art and may also be used. Other embodiments of an ARR frame may have alternate shapes, consist of multiple segments, or have alternately shaped mating features, tube orifices, or paddles.

6 6 6 6 FIGS.A-H, andJ-K 5 5 FIGS.A-B 1 1 FIGS.A-B 6 FIG.I 6 FIG.A 6 FIG.B 3 FIG.C 112 112 110 84 112 112 68 84 112 14 10 68 112 60 14 are a series of exploded views illustrating the assembly of one embodiment of an aortic root retractor which includes the aortic root retractor frame ofand a plurality of suture locking apparatuses of.was not used to avoid confusion with numeral one.illustrates a distal endD of a suture tubebeing inserted into one of the tube orificeson the ARR frame. On a proximal endP of the R-Non suture tubeis a flared end. This flared end can be molded, thermally formed, or machined according to methods known to those skilled in the art.shows the insertion of the ARR frameand suture tubeinto the lower housingof a suture locking apparatusas described in regard to. The flared endof the suture tubeis placed within the tube stopof the lower housing. Other embodiments may use an adhesive to fixedly attach the suture tube, alone or in conjunction with the flared end.

6 FIG.C 6 FIG.D 6 FIG.C 6 FIG.B 118 120 116 114 122 118 116 114 118 114 114 112 112 124 illustrates another assembly step of the embodiment of the aortic root retractor. A plastic targetdefining a groovearound its perimeter is shown being inserted into a snare loopof a suture snarealong axis. The targetprevents the snare loopfrom kinking or closing until such time as the snareis utilized in a minimally invasive surgical procedure. Alternate embodiments may be assembled by looping a suture snare around the target, followed by the formation of the snare loop directly onto the target by twisting the snare, adding a knot, or other mechanical fastener. The targetcan be composed of a plastic, elastomeric, or other material, and may alternatively be color coordinated for visual identification with a particular step of a surgical procedure, which may be advantageous to a surgeon or surgical team. In, the snare assembly fromis combined with the initial suture tube assembly ofby inserting the proximal endP of the snareinto the distal endD of the suture tubealong axis.

6 FIG.E 84 10 12 14 138 114 114 14 14 126 128 130 132 134 126 114 114 134 126 136 126 130 114 126 114 126 114 10 128 114 132 10 126 illustrates the completion of an ARR frameand single suture locking apparatusassembly. An upper housingis snapped onto the lower housingalong axis, with a distal endD of snareprotruding from the distal endD of the lower housing. A chalice, also referred to as a metal snare tab defines a handle, a neck, and a flared endhaving an openingthat travels through the entire length of the chalice. The distal endD of the snareis inserted into the openingof the R-Non chalicealong axisand is fixedly attached to the chaliceby crimping the neckand permanently holding the snarewithin the chalice. The snaremay also be held in place by other means known to those skilled in the art, such as adhesion or other mechanical fastening methods. The chaliceprovides several advantages when used in conjunction with a snareand suture locking apparatussuch as those described herein. The handleprovides a larger, more ergonomic place to grasp and pull a suture snarethrough a suture tube, while the flared endinterfaces with the notch in the distal end of the suture locking apparatusto prevent the suture locking mechanism from being prematurely actuated, for example, before the suture snare and accompanying suture has been pulled through the distal end of the suture locking apparatus. Other alternatives to the chalicemay be used, such as hooks, handles, knobs, or other grips. These may be made from metal, plastic or other material of sufficient physical integrity for the intended purpose.

6 FIG.F 5 FIG.A 6 FIG.F 84 84 84 140 126 112 118 116 114 142 146 150 154 160 144 148 152 156 164 84 88 90 92 illustrates a subassembly of the ARR frameand three suture locking apparatuses. The ARR frameis shown in an unfolded orientation as similarly depicted in. As the ARR frameis designed for use during a minimally invasive surgical procedure for the retraction and stabilization of cardiac tissue, the various elements in the devices and apparatus described herein shall be named in accordance with their associated anatomical structures. While it is possible that the ARR frame could be used in other surgical applications, the used described herein and the associated anatomical naming will be used herein. Further details of the devices and apparatus disclosed herein and how they coordinate with the anatomical features of the cardiac tissue will be discussed in further detail.shows an R-Non suture locking apparatushaving an R-Non chalice, R-Non suture tube, and an R-Non targetinserted within an R-Non snare loopof an R-Non snare. Similar structures are shown in regard to the L-Non suture locking apparatus, L-Non chalice, L-Non suture tube, L-Non target, and L-Non snare loop, as well as the L-R suture locking apparatus, L-R chalice, L-R suture tube, L-R target, and L-R snare loopand will be discussed in further detail. The unfolded orientation of the ARR frameand the relative locations of the first paddle, second paddle, and third paddleare also shown.

6 FIG.G 4 4 FIGS.A-B 112 150 152 104 108 110 166 100 96 94 96 84 101 166 168 94 98 84 is a proximal-right-top perspective view of the ARR frame ofthreaded with a deployment suture. In the preceding figures, the various suture tubes,,have been inserted into the tube orifices,,, but they are removed here for the purposes of illustrating the threading of the deployment suture. The deployment suture is threaded into suture guide, over to one of the suture guides, under the first geometric mating feature, out of the other suture guide, across the ARR frameand out through suture guide. The deployment sutureis now threaded in such a manner that when the suture endsare tightened, the first geometric mating featureand second geometric mating featurewill be drawn together, their surfaces will mate, and the ARR framewill be configured in a fully deployed state. This deployment mechanism can be activated from outside the body by a surgeon, such as through a cannula and into a minimally invasive surgical site, as one example.

6 FIG.H 6 FIG.J 6 FIG.H 170 14 10 172 170 60 14 174 168 166 170 170 176 140 142 144 112 150 152 118 154 156 shows the insertion of a deployment suture tubeinto the lower housingof a suture locking apparatus. The flared endof the deployment suture tubeis placed within the tube stopof the lower housingalong axis.is an exploded view showing the insertion of the suture endsof the deployment sutureinto a distal endD of the deployment suture tubeassembly shown inalong axis. The assembled locations of the R-Non suture locking apparatus, L-Non suture locking apparatus, L-R suture locking apparatus, and their respective suture tubes,,, and their respective targets,,are shown.

6 FIG.K 5 5 FIGS.A-B 1 1 FIGS.A-B 168 166 170 14 14 12 14 180 168 166 178 178 168 184 182 166 shows an assembly step of the aortic root retractor frame ofand a plurality of suture locking apparatuses of. The suture endsof the deployment suturehave been inserted into the deployment suture tubeand are now protruding from the distal endD of the lower housing. An upper housingis snapped onto the lower housingalong axis. The suture endsof the deployment sutureare inserted into the deployment suture chaliceand are fixedly attached to the chalicecrimping the suture endswith a mechanical fasteneralong axis. The deployment suturemay also be held in place by other means known to those skilled in the art, such as adhesion or other mechanical fastening methods. Alternate embodiments similar to those described herein may include alternately shaped pulls, tabs, or chalices than those disclosed.

7 FIG.A 1 FIG.A 7 FIG.A 2 2 FIGS.A andE 7 FIG.A 7 FIG.B 1 FIG.A 7 FIG.B 34 46 10 46 10 46 34 46 34 is a right cross-sectional elevational view of the suture locking apparatus ofin an unlocked position.is the cross-section previously denoted in.shows the relative position of the latch stepand the latch tabof the suture locking apparatuswhile in the unlocked position.is a right cross-sectional elevational view of the suture locking apparatus ofin a locked position.shows the relative position of the latch step and the latch tabof the suture locking apparatuswhile in the locked position. The latch tabsneed to be pushed away from the latch stepso that the latch tabscan clear the latch step.

8 8 FIGS.A-B 1 FIG.A 8 FIG.A 8 FIG.A 7 FIG.A 183 185 24 10 186 185 50 60 44 42 12 14 16 10 10 12 14 186 188 185 185 60 183 34 46 are right-side elevational views of a suture locking device which includes the suture locking apparatus ofin an unlocked and locked position, respectively.is a right-side elevational view of an embodiment of a suture locking devicein an unlocked position. In this view, a suture tubeis inserted into the distal apertureof the suture locking apparatus, and a sutureis inserted into and guided through the suture tubethrough the channel, past the tube stop, through the lower tooth recessesand exits via the proximal aperture.further shows the upper housingand the lower housingmoved pivotably around the hingesuch that the distal endsD are in closer proximity than the proximal endsP of the upper housingand the lower housing. In this orientation, the entire sutureincluding the suture endsmoves freely within the suture tubewhile the suture tubeis held securely at the tube stopwithin the suture locking device. This unlocked position corresponds to the latch stepand latch tabposition in.

8 FIG.B 7 FIG.B 8 FIG.B 183 38 10 10 34 46 12 14 16 10 10 12 14 12 14 186 188 185 60 183 is a right-side view of the suture locking devicein a locked position. To engage the locking mechanism, the operator applies a force to the recessat the proximal endP of the suture locking apparatus. This locked position corresponds to the latch stepand latch tabposition in.further shows the upper housingand the lower housingmoved pivotably around the hingesuch that the proximal endsP are in closer proximity than the distal endsD of the upper housingand the lower housing. In this orientation, the gripping surfaces of the upper housingand the lower housingare in closer contact, the sutureis firmly locked, the suture endswill not move, and any motion is restricted while the suture tubeis also held securely at the tube stopwithin the suture locking devicewhile in either the locked position or the unlocked position. This reversible locking and unlocking mechanism, or releasable locking mechanism can be advantageous if sutures are to be adjusted multiple times during a surgical procedure.

9 FIG. 1 FIG.A 9 FIG. 9 FIG. 190 190 194 196 198 198 196 198 198 190 212 202 212 200 196 192 190 198 190 190 212 192 198 190 190 192 192 is a right-side elevational view of a suture management device which includes the suture locking apparatus of. The suture management devicecan be used in surgical procedures for the temporary management, application and maintenance of tension on sutures. In this embodiment, while the suture locking apparatusis in the unlocked position (as shown), a plastic targetcan be removed from a wire snarecontained at the distal endD of a suture tube. The snarealso runs through the tube, passing out of a proximal endP, and exiting the suture locking deviceand culminating in a curved metal handleconnected to the proximal end of the snare. A chalice or other aforementioned alternatives may be used in place of the metal handle. Two ends of a suture (not shown in this view) are passed through a loopin the wire snareat the distal endD of the suture management deviceand the suture is snared and pulled through the suture tubetowards the proximal endP of the suture management deviceusing the handleto pull. The suture locking apparatusis configured to secure the suture inside the tubewhen the suture locking apparatusis locked, thereby removing the need for a larger clamp requiring more than one hand or additional assistance to operate. The suture locking apparatus provides an advantage of single-handed operation. Whileshows only one embodiment of a suture management devicewith a suture locking apparatusin use, it is understood that other embodiments and other suture management devices could utilize suture locking devicessimilar to those described herein. The suture locking apparatuses utilized in a procedure requiring the use of such devices depicted in, could facilitate a more convenient method of locking multiple sutures during a complex, minimally invasive surgical procedure.

10 FIG.A 5 5 FIGS.A-B 10 FIG.A 10 10 FIGS.A andB 204 204 208 206 218 206 222 220 216 208 210 204 204 204 204 216 214 212 210 214 220 206 214 216 204 is a proximal-top-left perspective view of an alternate embodiment of a suture locking apparatus used in combination with the aortic root retractor frame of. The resulting ARR deviceis used in minimally invasive surgical procedures for the retraction and stabilization of cardiac tissue during heart valve replacement. The embodiment of the ARR deviceshown inincludes an ARR frameconnected to a suture locking deviceby a suture tubethe suture locking devicealso includes a deployment suturelooped around a target. There are also three additional suture tubesinserted into the ARR framecarrying snares, as previously described, with commissural target snare loopson the distal endD of the ARR Device. On the proximal endP of the ARR Device, each suture tubehas a targetinserted into the snare (not shown in this view) with a handleattached thereto. In some embodiments, the target,,at either end of each commissural suture snare loops may have a unique identifier, such as being color coded for easier visualization and suture management during a procedure. Furthermore, the suture locking devicethat may be used in place of the targetson one or all of the suture tubesmay be color coded as well. The procedure related to the use of the embodiment of the ARR deviceillustrated inare described in regard to later embodiments.

10 FIG.B 5 5 FIGS.A-B 10 FIG.A 205 204 207 216 214 205 207 212 207 is a proximal-top-left perspective view of an alternate embodiment of a plurality of suture locking apparatuses used in combination with the aortic root retractor frame of. This embodiment of an ARR deviceis similar to the ARR deviceillustrated in, but also includes additional suture locking apparatuseson the other three suture tubes. This embodiment does not include targetsat the proximal endP of each of the suture locking apparatusesbut has several curved handlesprotruding from the suture locking apparatuses.

11 FIG. 15 15 15 15 15 15 FIGS.A-J,K-N, andP-Q 224 226 228 230 232 226 140 142 144 238 140 142 144 238 140 142 144 238 224 is a distal-top-left perspective view of one embodiment of an aortic root retractor (ARR) delivery device. The aortic root retractor (ARR) delivery devicehas a housingwith a handle, an actuation lever. There is a suture lock organizer, or chariot at the distal end of the housingconfigured to releasably hold four suture locking apparatus, the R-Non suture locking apparatus, L-Non suture locking apparatus, L-R suture locking apparatus, and the deployment suture lock apparatus. The suture lock apparatuses,,,are each placed in a specific location (in this embodiment, left to right from the point of view of the operator) in the suture lock organizer for the purpose of arranging the suture lock apparatuses suture lock apparatuses,,,on the aortic root retractor (ARR) delivery deviceaccording to the order in which they will be utilized in a specific surgical procedure, such as the one described later in regard to. This organization has the advantage of being ergonomically efficient for the operator and has an instructional benefit for teaching surgical procedures or providing a reminder the progress completed in a surgical sequence. Another unique identifier for suture locking apparatuses in this or alternate embodiments of an ARR delivery device may be to have suture locking apparatuses each with a color distinct from one another, which also has a benefit for the operator with regard to ergonomics, instructional value, accuracy, or efficiency. The unique identifier may also be in the form of a unique and distinct text label, image, pattern, or texture on each of the suture locking apparatuses. It could also be in the form of differently sized or shaped suture locking apparatuses. These unique identifiers as listed could also be located or embodied within other elements of an ARR delivery device such as the chalice or snare tab, or on the handle, for example.

242 226 240 242 84 240 140 126 112 118 116 114 142 146 150 154 160 144 148 152 156 164 224 238 170 166 84 224 5 5 FIGS.A-B 6 FIG.K A shaftextends from the housingand has an introducer endat the end of the shaft. An ARR frame, as described in regard to, is releasably held in the introducer endor introducer tip. The subassembly completed inincluding the R-Non suture locking device, R-Non chalice, R-Non suture tube, R-Non target, R-Non snare loop, R-Non snare, L-Non suture locking apparatus, L-Non chalice, L-Non suture tube, L-Non target, L-Non snare loop, and L-Non snare (not shown) as well as the L-R suture locking apparatus, L-R chalice, L-R suture tube, L-R target, L-R snare loop, and L-R snare (not shown) is loaded into the ARR frame introduction device. A deployment suture lock apparatushaving the deployment suture tubeand the deployment suturewithin are attached to the ARR frameand also loaded into the ARR frame introduction device.

12 12 FIGS.A-G 11 FIG. 6 FIG.K 12 FIG.A 240 244 242 242 246 248 250 242 242 248 240 240 250 246 256 254 262 254 256 258 260 258 254 254 260 230 254 242 224 are a series of exploded views of various stages of the assembly of the aortic root retractor (ARR) delivery device ofwhich includes the aortic root retractor of.is an assembly step showing the introducer endbeing inserted along an axisinto the distal endD of a shaft. An introducer pinhaving a pin tipand a ball endis inserted through the proximal endP of the shaftuntil the pin tipis held within the introducer endthrough a pin path that travels throughout the length of the introducer end. The ball endof the introducer pinis inserted into and held within a ball connector recessof a gear assemblyalong an axis. The gear assemblydefines the ball connector recess, two axles(one on either side), and a gear. The axleson either side of the gear assemblyare each configured to interface with a recess in either side of the device housing and allow the gear assemblyto pivot when the gearis actuated by the actuator lever(not shown in this view). This pivoting of the gear assemblythen moves the introducer pin back and forth along the shaftduring operation of the ARR frame introducer device.

12 FIG.B 12 FIG.B 224 264 272 274 270 268 276 234 236 268 230 231 278 280 231 230 272 264 294 282 284 286 284 280 230 292 286 276 264 296 282 230 228 is an exploded view of a subsequent assembly step of the aortic root retractor frame introduction device. A first housing halfdefines a pivot axle recess, a shaft recess, a gear recess, a tether recess, and a spring retainer. A tetherdefining a tether notch, configured to releasably hold one or more pair of sutures, is placed in the tether recess. An actuation leveris shown inwhich has two opposing axles(only one is visible here), a lever gear, and a spring attachment. One axleon the actuation leveris inserted into the pivot axle recesson the first housing halfalong an axis. A spring, having a hookand a loopis attached at the hookonto the spring attachmenton the actuation leveralong axis, and attached at the looponto the spring retaineron the first housing halfalong an axis. In this arrangement, the springbiases the actuator leverin an unsqueezed, non-actuated position, or a position away from the handleonce the assembly is completed.

12 FIG.B 12 FIG.A 264 258 254 270 264 290 254 264 278 260 254 266 266 264 258 231 254 230 276 264 266 274 264 242 266 224 Still on, the subassembly ofis placed into a first housing halfby inserting an axleof the gear assemblyinto a gear recessin the first housing halfalong an axis. When the gear assemblyis placed into the first housing half, the lever gearintermeshes with gearon the gear assembly. Next, the second housing halfis assembled in place. The second housing halfhas similar recess features to the first housing half(these features are not shown in this view) to accommodate the respective axles,from the gear assemblyand actuation lever, respectively, as well as a mating feature to align the spring retainerof the first housing halfto a corresponding feature in the second housing half. Th shaft recessof the first housing halfalso holds the shaftwith the corresponding shaft recess (not shown here) on the second housing halfwhen assembled. Optionally, a means of temporarily restricting the lever from being squeezed are known in the art and may be implemented in an aortic root retractor frame introduction devicesuch as those described herein.

12 FIG.C 11 FIG. 12 FIG.B 224 224 226 228 230 242 240 232 233 302 304 306 308 302 304 306 308 312 140 144 142 238 302 304 306 308 302 304 306 308 310 140 144 142 238 140 144 142 238 302 304 306 308 232 240 242 314 232 226 242 233 232 298 300 242 240 242 314 300 298 298 242 232 226 298 242 is an exploded view of an assembly step of the aortic root retractor frame introduction device, or the ARR frame introduction deviceof. Following the assembly steps in, the ARR frame introduction deviceis shown with the completed housinghaving a handle, actuator lever, shaft, and introducer end. A suture lock organizerconfigured to releasably hold four suture locks has a center holeand four saddles, an L-Non saddle, an L-R saddle, an R-Non saddle, and a deployment saddle. Each saddle,,,defining a notchto accommodate and hold a suture tube and is configured to releasably attach a suture locking apparatus,,,into the corresponding L-Non saddle, L-R saddle, R-Non saddle, and deployment saddle, respectively. Each saddle,,,also has a recess featurethat corresponds to features of the suture locking apparatus,,,and is also configured to hold the suture locking apparatus,,,in each saddle,,,. The suture lock organizeris placed over the introducer endand onto the shaftalong an axissuch that the suture lock organizeris placed directly onto the housing. The shaftpasses through the center holeof the suture lock organizer. A retainerhaving a center holeis also placed over the shaft, the introducer endand shaftpassing along axisthrough the center holeof the retainer. The retaineris then fixedly attached to the shaftto effectively fasten the suture lock organizerto the housing. Any method of fixing the retainerto the shaft, such as screw fastening, brazing, adhering using an adhesive, or other methods known to those skilled in the art may be used. While one arrangement of saddles on a suture lock organizer are shown in this view, it should be noted that other embodiments of suture lock organizers, or similar means of releasably holding multiple suture locks to an aortic root retractor frame introduction device are known to those skilled in the art.

12 FIG.D 11 FIG. 6 FIG.K 12 FIG.C 12 12 FIGS.E andF 84 240 316 230 230 228 229 230 278 260 254 246 240 84 240 is an exploded view of an assembly step of the aortic root retractor frame introduction device of. The resulting subassembly ofis now combined with the resulting subassembly of. The ARR frameis first loaded onto the introducer endalong axis. The actuation leveris in a squeezed position, with the actuation leverpulled close to the handlein direction. This movement of the actuation leverturns the lever gearand the gearof the gear assembly, pulling back the introducer pin, thus removing it from the introducer end. This allows the ARR frameto be placed into the introducer end. This will be further detailed in.

12 FIG.E 12 FIG.F 224 230 228 325 140 144 142 238 112 152 150 170 84 240 98 84 342 240 246 101 318 84 240 84 106 344 320 230 246 106 338 334 240 illustrates an overview of the ARR frame delivery devicewith the actuation leverpartially released away from the handlein direction. The R-Non suture locking apparatus, L-R suture locking apparatus, L-Non suture locking apparatus, and the deployment suture locking apparatuswith the respective R-Non suture tube, L-R suture tube, L-Non suture tube, and the deployment suture tubeare in their assembly orientation. The ARR frame, in a folded orientation, is placed into the introducer end.shows the second geometric mating featureof the ARR frameplaced into the proximal frame gap(not shown in this view) of the introducer end, with the introducer pinpartially advanced through suture guideand partially advanced through bridge. To fully install the ARR frameinto the introducer end, the portion of the ARR framewith the pin receiving orificemust be placed into the distal frame gapalong axis, then the actuation leveris fully released, advancing the introducer pinthrough the pin receiving orificeand into the pin pathtowards a blunt tipof the introducer end.

12 FIG.G 11 FIG. 12 12 FIGS.E-F 12 FIG.G 84 240 230 327 140 306 326 144 304 324 142 302 322 238 308 328 224 is an exploded view of a final assembly step of the aortic root retractor frame introduction device of. The ARR frameis shown in a fully folded orientation captured within the introducer endfollowing the assembly steps described in regard to, and the actuation leveris shown in a fully released position, having moved in direction. In, the R-Non suture locking apparatusis placed in its saddlealong axis. In similar fashion, L-R suture locking apparatusis placed in its saddlealong axis, L-Non suture locking apparatusis placed in its saddlealong axis, and deployment suture locking apparatusis placed in its saddlealong axis, completing the assembly of the ARR frame delivery device.

13 13 FIGS.A andB 11 FIG. 15 15 15 15 15 15 FIGS.A-J,K-N, andP-Q 240 332 333 334 338 340 240 240 318 342 344 344 342 240 84 338 246 246 240 84 334 240 224 332 333 84 240 are distal-bottom-left and distal-bottom right perspective views of the introducer end of the aortic root retractor (ARR) delivery device of, respectively. The introducer endor introducer tip defines two positioners,, a blunt tip, and an introducer pin pathtraveling through the bodyof the introducer end. The introducer endfurther defines a bridgewhich is a protrusion that further defines a proximal frame gapand a distal frame gap. The distal frame gapand proximal frame gapare spaces in the introducer tipto accommodate separate portions of the folded ARR framebefore deployment. The introducer pin pathaccommodates the introducer pinand is configured to guide and allow the introducer pinto freely pass through various channels defined by the introducer endto hold and release the folded ARR framein various stages of the ARR delivery procedure. These stages of delivery or introduction will be described further in regard to. The blunt tipof the introducer endis rounded or blunt and configured to reduce the potential of tissue trauma when using the aortic root retractor frame introduction device. Each positioner,is configured to help position the ARR framein to its final position before deployment during a surgical procedure. The introducer endis connected to the shaft of the device during assembly by screws, welding, adhesion, or other means known to those skilled in the art.

14 FIG. 11 FIG. 234 226 235 140 142 144 236 234 224 235 234 236 is a proximal-top-right perspective view of part of the aortic root retractor (ARR) delivery device ofillustrating the use of the suture tether. This view depicts the use of the tethermounted to the housingwhen multiple suture endsare pulled through and locked within each of the suture locking devices,,. The suture ends are releasably held within the tether notchof the tetherby a friction fit. If the lengths or the tautness of one or more of the suture ends are adjusted during a minimally invasive surgical procedure using the ARR frame delivery device, the suture endscan be easily removed from the tether, adjusted and reinserted into the tether notchto be held once more.

15 15 15 15 15 15 FIGS.A-J,K-N, andP-Q 11 FIG. 15 15 FIGS.I andO 15 FIG.A 15 FIG.B 15 FIG.A 15 FIG.C 15 FIG.A 348 358 350 354 360 352 356 358 350 354 353 357 361 348 358 350 354 348 362 348 84 84 are a series of views detailing portions of a surgical procedure using the aortic root retractor (ARR) delivery device of.were not used to avoid confusion with numerals one and zero, respectively.is a view of the aortic annulusin preparation for a minimally invasive surgical procedure involving the retraction and stabilization of cardiac tissue, including the aortic root. Three commissural stay sutures—an L-Non commissural stay suture, an L-R commissural stay suture, and an R-Non commissural stay suture—have been placed in each of the L-Non commissure, L-R commissure, and R-Non commissures. The L-Non commissural stay suture, L-R commissural stay suture, and R-Non commissural stay sutureextend out of a minimally invasive surgical site (not shown in this view). The locations of the right coronary sinus, non-coronary sinus, and left coronary sinusare also indicated.is a view of the aortic annulusof. The L-Non commissural stay suture, L-R commissural stay suture, and R-Non commissural stay sutureare shown in place, and the aortic valve leaflets have been removed.is a view of the aortic annulusof. In this view a soundis probing the aortic annulusprior to the delivery of the ARR frameto determine an appropriate ARR frame size and an appropriate prosthetic valve size. This sizing decision would be determined and confirmed by visual inspections. The aortic annulus and the aortic root are better visualized during subsequent surgical procedures with the ARR frameinserted.

15 FIG.D 11 FIG. 15 FIG.E 11 FIG. 15 FIG.D 224 348 164 156 358 164 148 142 364 358 150 142 224 348 358 234 226 224 350 148 144 354 126 140 142 144 140 238 is a proximal-top-left perspective view of the ARR frame introduction deviceofprepared for use in a surgical procedure with the aortic annulusin view. The L-Non snare loophas been exposed, with the targethaving been removed as described previously. The L-Non commissure suture endsE or tails have been passed through the L-Non snare loop. The metal snare tab or chalicemounted onto the L-Non suture locking apparatusis then pulled in a proximal directionin order to pull the L-Non commissure stay suturethrough the L-Non suture tubeand into the L-Non suture locking apparatus.is a proximal-top-left perspective view of the ARR frame introduction deviceofin use in a surgical procedure with the aortic annulusin view. The L-Non commissure suture endsE are held within the tether. This and other suture ends may be further secured by the thumb of the operator's hand while resting on the housingof the ARR frame delivery device. The steps described in regard toare subsequently repeated (but not shown in this view) with the L-R commissure stay suture endsE, L-R chalice, L-R suture locking apparatus, and with the R-Non commissure stay suture endsE, R-Non chalice, R-Non suture locking apparatus, respectively. The L-Non suture locking apparatus, L-R suture locking apparatus, and R-Non suture locking apparatusare not locked at this stage, and no action is taken relative to the deployment suture locking apparatusat this stage.

15 FIG.F 11 FIG. 15 FIG.A 15 FIG.G 15 FIG.F 224 84 348 84 350 354 358 366 348 350 354 358 234 84 348 332 333 240 90 84 357 358 150 150 84 84 348 360 350 354 358 142 144 140 142 144 140 232 224 112 150 152 84 348 84 224 90 84 357 238 232 224 is an enlarged proximal-top perspective view of the ARR frame introduction deviceofin use during a surgical procedure. The collapsed ARR frameis delivered to the aortic annulusby moving the device or parachuting the ARR framedown along the commissural sutures,,in a distal directiontowards the aortic annuluswhile the operator grasps and takes up any slack on the suture endsE,E, andE behind the tether. The ARR frameand its paddles are guided and oriented by the operator into the aortic root of the aortic annulus, with assistance by the use of forceps or one of the positioners,on the introducer tipif necessary. Initially, the second paddleof the aortic root retractor frameis oriented into the non-coronary sinus. While not completely shown in this view, the L-Non commissure stay sutureis fully pulled through the L-Non suture tube, positioning the L-Non suture tubeagainst the ARR frame, fully securing the ARR frameto the aortic annulusat the L-Non commissure stay suture location. While maintaining tension on the suture endsE,E, andE, the L-Non suture locking apparatus, L-R suture locking apparatus, and R-Non suture locking apparatusare closed and locked. The L-Non suture locking apparatus, L-R suture locking apparatus, and R-Non suture locking apparatusare each in turn removed from the suture lock organizerof the ARR frame delivery deviceand placed in the appropriate location on a suture management system and secured. This action of tightening each of the commissural stay sutures serves to align the suture tubes,,and therefore the ARR framewith the initial suture locations described in regard to.is an enlarged perspective view of the aortic annuluswith the collapsed or folded ARR frameand the ARR frame introduction devicein their respective positions as described in regard to. The relative locations of the second paddleof the aortic root retractor frameand the non-coronary sinusshould be noted. At this stage, the deployment suture locking apparatusis removed from the suture lock organizerof the ARR frame delivery deviceand placed in a suture management system.

15 FIG.H 11 FIG. 15 15 15 FIG.H andJ-N 15 FIG.J 15 FIG.H 15 FIG.J 224 246 224 224 224 230 228 240 224 84 240 246 101 98 84 342 240 246 106 84 344 240 84 230 368 228 is a bottom-left perspective view of the ARR frame introduction deviceofshown with the introducer pinin an engaged position.illustrate the ARR frame delivery deviceoutside of the surgical context and in the absence of tissue in order to clearly represent the operation of the ARR frame introduction device. The ARR frame introduction deviceis shown with the actuation leverreleased in a direction away from the handle.is an enlarged partial cross-sectional view of the introducer endof the ARR frame delivery deviceof.shows the ARR frameloaded into the introducer end, with the introducer pinengaged through suture guidein the second geometric mating featureof the ARR frame, which is held within the proximal frame gapof the introducer end, and the introducer pinengaged through the pin receiving orificeof the ARR frame, which is held within the distal frame gapof the introducer end. To begin the release of the ARR frame, the actuator leveris squeezed in a direction towardsthe handle.

15 FIG.K 11 FIG. 15 FIG.L 224 246 230 368 228 246 240 246 344 240 246 106 84 84 246 240 101 84 101 98 84 342 240 224 88 84 352 348 is a bottom-left perspective view of the ARR frame introduction deviceofshown with the introducer pinin a partially released position. The actuation leveris partially squeezed in a direction towardsthe handle, which retracts the introducer pinpartially away from the introducer end. This moves the introducer pin, as shown in the enlarged view of, out of the distal frame gapof the introducer end. This also releases the introducer pinfrom the pin receiving orificeof the ARR frame, allowing the ARR frameto partially unfold. The introducer pinremains in the bridge of the introducer endand in suture guideof the ARR frame, thereby retaining the suture guideof the second geometric mating featureend of the ARR framein the proximal frame gapof the introducer endof the ARR frame introduction device. At this stage, the first paddleof the folded ARR frameis released and is guided past the L-R commissureand into the aortic annulus.

15 FIG.M 11 FIG. 15 FIG.N 224 246 230 368 228 246 240 246 342 240 246 101 98 84 84 224 246 84 342 240 224 is a bottom-left perspective view of the ARR frame introduction deviceofshown with the introducer pinin a fully released position. The actuation leveris fully squeezed in a directiontowards the handle, which retracts the introducer pinfully away from the introducer end. This moves the introducer pin, as shown in the enlarged view of, out of the proximal frame gapon the introducer end. This releases the introducer pinfrom suture guideof the second geometric mating featureend of the ARR frame, allowing the ARR frameto be fully released from the ARR frame introducer device. The introducer pinis fully retracted, thereby releasing the ARR framefrom the proximal frame gapof the introducer endof the ARR frame introduction device.

15 FIG.P 11 FIG. 15 15 FIGS.M andN 15 FIG.Q 224 84 240 224 370 238 178 238 84 348 238 238 170 348 84 is an enlarged perspective view of the ARR frame introduction deviceofin use during a surgical procedure. Once the ARR frameis fully released from the introducer tipas described in regard to, the ARR frame delivery devicemay be removed from the aortotomy or surgical location in a proximal directionaway from the patient. The deployment suture lock apparatusand its corresponding metal snare tab or chaliceis pulled away from the deployment suture lock apparatusto fully expand the ARR framewithin the aortic annulus. The deployment suture lock apparatusis then locked and the deployment suture lock apparatusand its deployment suture tubeare set aside in a suture management apparatus.is a perspective view of the aortic annuluswith the ARR framefully deployed and secured.

348 84 84 144 142 140 238 150 152 112 170 84 350 354 358 15 15 15 15 15 15 FIGS.A-J,K-N, andP-Q Once the aortic annulusis prepared for subsequent surgical procedure steps, the ARR frameis removed, for example, before a prosthetic valve is parachuted down to the annulus. To release and remove the ARR frame, the suture locking apparatus,,,are unlocked and their respective suture tubes,,and the deployment suture tubeare released. All sutures are cut and removed, the ARR frameis unfolded from around the annulus sutures, then retrieved by forceps or an alternate grasper. Finally, the three commissural stay sutures,,are removed from the surgical site. While the preceding procedural steps described in regard tohave been disclosed, other alternative procedural steps to achieve similar results could potentially be completed using an ARR frame delivery device as described herein.

16 16 FIGS.A-B 372 376 378 380 384 386 372 380 372 84 384 246 246 380 84 378 372 376 386 372 84 are distal-top-right and distal-top-left perspective views of an alternate embodiment of an introducer end of an aortic root retractor (ARR) delivery device, respectively. The introducer enddefines a positioner, a blunt tip, a frame gap, and an introducer pin pathon the bodyof the introducer end. The frame gapis a space in the introducer tipto accommodate a folded ARR framebefore deployment. The introducer pin pathaccommodates the introducer pinand is configured to guide and allow the introducer pinto freely pass through the frame gapto hold and release the folded ARR frame. The blunt tipof the introducer endis rounded or blunt and configured to reduce the potential of tissue trauma when using an aortic root retractor frame introduction device such as those described herein. The positioneris a protrusion from the bodyof the introducer endconfigured to help position the ARR frameinto its final position before deployment during a surgical procedure.

17 19 FIGS.- 17 FIG. 18 FIG. 19 FIG. 11 FIG. 388 392 394 396 400 402 404 408 410 412 418 416 412 414 414 416 416 420 404 are distal-top-right perspective views of alternate embodiments of an aortic root retractor (ARR) delivery device.is a distal-top-right perspective view of an alternate embodiment of an aortic root retractor frame introduction device. This embodiment of an aortic root retractor frame introduction deviceillustrates a straight in-line orientation of the suture locking apparatusand deployment suture locking apparatus.is a distal-top-right perspective view of an alternate embodiment of an aortic root retractor frame introduction device. This embodiment illustrates a rounded orientation of the suture locking apparatusand deployment suture locking apparatus.is a distal-top-right perspective view of an alternate embodiment of an aortic root retractor frame introduction device. This embodiment shows an arrangement of the suture locking apparatusand deployment suture locking apparatussimilar to the embodiment shown in, but with an additional tube guide wheelattached to the shaftused for improved organization of suture tubes. The suture tube guide wheeldefines several notchesaround its circumference. These notchesare sized and configured to releasably hold via a light friction fit any number of suture tubesfor improved organization and management of suture tubes. This embodiment further has a lever block, which is a physical inhibitor to prevent the ARR frame introduction devicefrom being actuated prematurely.

Various advantages of devices for cardiac surgery have been discussed above. Embodiments discussed herein have been described by way of example in this specification. It will be apparent to those skilled in the art that the foregoing detailed disclosure is intended to be presented by way of example only, and is not limiting. Various alterations, improvements, and modifications will occur and are intended to those skilled in the art, though not expressly stated herein. These alterations, improvements, and modifications are intended to be suggested hereby, and are within the spirit and the scope of the claimed invention. As just one example, although many of the embodiments shown herein included six suture guides, it should be understood that other embodiments may have more or fewer suture guides. As another non-limiting example, the suture guide holes shown in the embodiments herein are fully constrained holes. In other embodiments, the suture guide holes could be in communication with an access channel that would allow a suture to be brought into the suture guide hole by guiding a middle portion of a suture through the access channel and into the suture guide hole. This could avoid the need for a snare to pull the suture through the guide hole in some embodiments. Additionally, the recited order of processing elements or sequences, or the use of numbers, letters, or other designations, therefore, is not intended to limit the claims to any order, except as may be specified in the claims. Accordingly, the invention is limited only by the following claims and equivalents thereto.